Effect of the Built Operating Room Environment on Patient Outcome

NCT03037905 | Completed Results

• 1 other identifier: CCF15-009
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Anxiety prior to surgery is an expected emotion. Research has not been conducted on methods to reduce anxiety in the operating room itself. STERIS Corporation has developed an automated surgical suite environmental system, called SignatureSuite™, that controls the level of lighting, images on OR monitors, and ambient background audio via preset, computerized automation for use before and after anesthesia. This study aims to determine if this new type of operating room environment decreases anxiety, as measured by patient responses on anxiety visual analog scales, heart rate, systolic blood pressure, and postoperative analgesic use. The proposed study will be a two-arm, randomized controlled trial comparing anxiety levels for patients that have thyroid or parathyroid surgery in the SignatureSuite room at Cleveland Clinic Marymount Hospital versus the standard operating room environment. Randomization will occur at the surgeon level. There will be a maximum 100 patients divided equally between the experimental and control arms of the study.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• Change (Difference) in Anxiety

  Change (difference) in anxiety level as measured by a 100 millimeter line visual analog scale from baseline (pre-operative) to arrival in post anesthesia care unit (post-operative).The anxiety visual analog scale quantifies current state of anxiety. It is measured on a 100 millimeter line with anchors "No anxiety" to "The most anxiety I can imagine." Participants make a mark across the line to represent their current state of anxiety. A millimeter ruler is used to measure from left to right with the number of millimeters recorded where the mark crosses the line, minimum score is 0 and maximum score is 100. Higher number means more anxiety.

  Pre-operatively to post-operatively

Secondary Outcomes (2)

• Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures

  Pre-operative to post-operative

• Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates

  Pre-operative to post-operative

Other Outcomes (1)

• Analgesic Use

  Postoperatively

Study Arms (2)

SignatureSuite OR

EXPERIMENTAL

The intervention is exposure to the operating room environment created by the device SignatureSuite OR Integration System by STERIS Corporation.

Device: SignatureSuite OR Integration System by STERIS Corporation

Standard OR

NO INTERVENTION

Standard operating room without SignatureSuite OR Integration System by STERIS Corporation.

Interventions

SignatureSuite OR Integration System by STERIS Corporation DEVICE

SignatureSuite OR Integration System by STERIS Corporation is a device that controls audio and visual components of the operating room environment in order to provide a more relaxing and calming operating room environment for patients prior to surgery and on emergence from anesthesia after surgery.

Also known as: SignatureSuite

SignatureSuite OR

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• able to read and understand English;
• presentation for thyroid and/or parathyroid surgery at Marymount Hospital;
• visual capacity to complete the VAS

You may not qualify if:

• history of documented anxiety/depression disorder
• currently taking medications for depression/anxiety
• currently taking anticonvulsant medication and/or gamma-Aminobutyric acid analogs
• unable to read and understand English
• dementia
• vision loss making it impossible to complete the anxiety visual analog scale
• currently taking beta-blockers
• surgeon refusal for patient participation
• intra-operative emergency, such as cardiac incident requiring resuscitation or stabilizing medications, unplanned extubation, or early emergence from anesthesia
• other patient-related reasons that would affect eligibility to participate.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• STERIS Corporation: collaborator

Study Sites (1)

Cleveland Clinic Marymount Hospital

Garfield Heights, Ohio, 44125, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Limitations and Caveats

Study was conducted at one community hospital in Northeast Ohio. Study population limited to patients having thyroid or parathyroid surgery. Low dose anxiolytic given intravenously in the preoperative holding area prior to being moved to the OR.

Results Point of Contact

• Title: Christian N. Burchill, PhD, RN, CEN
• Organization: Cleveland Clinic

burchic@ccf.org

216-445-9317

Study Officials

• Christian N Burchill, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Scientist II

Study Record Dates

• First Submitted: September 11, 2016
• First Posted: January 31, 2017
• Study Start: January 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 16, 2020
• Results First Posted: November 22, 2017

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)